Sterile surgical drape for ophthalmic surgery

ABSTRACT

The disclosure herein provides methods, systems, and devices for a sterile ophthalmic surgical drape system that can provide a sterile operating field for use by a doctor, surgeon, nurse, and the like during ophthalmic medical procedures. The sterile field created by the drape system can allow a doctor, surgeon, nurse and the like to perform a medical procedure, such as ophthalmic surgery, outside of an operating room and in locations such as a doctor&#39;s office or a military operating room war setting. The sterile ophthalmic surgical drape system can comprise a drape, a frame apparatus, a hole of sufficient size for a microscope, a fan, a filter, air directors, and slits. The drape system can comprise a collapsible frame apparatus. The drape system may be configured to be used in conjunction with a surgical tray that houses pre-sterilized tools for use in a medical procedure.

PRIORITY CLAIM

This application is a continuation application of U.S. Non-provisionalapplication Ser. No. 16/659,927 filed Oct. 22, 2019, which is acontinuation of U.S. Non-Provision application Ser. No. 14/419,926 filedFeb. 5, 2015, which is a 371 national stage application of PCTapplication PCT/2013/053652, whose inventors are Ralph Kerns, MarkHumayun and Matthew T. McCormick (both of which are hereby incorporatedby reference in their entirety as though fully and completely set forthherein). This application further claims priority to U.S. ProvisionalApplication No. 61/680,192 filed Aug. 6, 2012, whose inventors are RalphKerns, Mark Humayun and Matthew T. McCormick (which is also herebyincorporated by reference in its entirety as though fully and completelyset forth herein) (PCT/2013/053652 claimed priority to U.S. ProvisionalApplication No. 61/680,192).

BACKGROUND Field

The embodiments of the disclosure generally relate to ophthalmic surgeryand more particularly to sterile ophthalmic surgical drape systems.

Description

With the development of new technologies, various types and kinds ofdrapes have been developed for ophthalmic surgical procedures. Thesedrapes typically consist of a thin material that is placed on a patientand adheres to a patient's skin. Ophthalmic surgical drapes help isolatethe surgical site from the adjacent facial structures, such aseyelashes, eyebrows, the nose and the mouth. The material generally hasa circular- or rectangular-shaped cutout through which a user such as adoctor, surgeon, or nurse may observe the eye and perform medicalprocedures. Despite the use of ophthalmic surgical drapes in medicalprocedures, doctors and surgeons are limited by when and/or where theymay perform medical procedures because of the need for a sterilizedoperating field. A sterile field is generally established for manymedical procedures, including ophthalmic surgery. Generally a sterilefield refers to the surgical site as well as a surround area thatspecifies an area that is considered free from microorganisms. Such asterile field can be used to prevent contaminants from infecting the eyeduring operation. Traditionally, a doctor or surgeon may only haveaccess to a sterile operating field by scheduling a procedure in anexpensive, sterilized operating room in a hospital.

SUMMARY

Advancements in ophthalmic surgical drape system technology make itpossible to perform a medical procedure, such as ophthalmic surgery, ina sterile operating field outside of an operating room in locations suchas a doctor's office or a military operating room war setting.

In accordance with one aspect, a device for performing surgerycomprising: a drape, the drape comprising a hole configured to allow atleast one accessory device to be placed in the hole and to access asurgical site covered by the drape; a frame, the frame comprising anupper rim, a lower rim, and one or more legs, wherein the one or morelegs can connect the lower rim to the upper rim of the frame, whereinthe drape is configured to be coupled to the frame to define an interiorsurgical chamber; and a fan, the fan configured to generate pressurizedair within the interior surgical chamber, the fan comprising a filter,the filter configured to sanitize the pressurized air. In someembodiments, the fan is coupled to the frame. In some embodiments,wherein the drape is releasably coupled to the frame. In someembodiments, wherein the frame is collapsible. In some embodiments,wherein the one or more legs are configured to be deformable. In someembodiments, wherein the at least one accessory device comprises amicroscope.

In some embodiments, wherein the fan is configured to generate apressurized air of about 0.5 psi. In some embodiments, wherein fan isconfigured to generate a pressurized air of about 1 psi. In someembodiments, wherein the fan is configured to generate a pressurized airof about 2 psi. In some embodiments, wherein the fan is configured todraw air into the interior surgical chamber. In some embodiments,wherein the fan is configured to be located on a side portion of theframe. In some embodiments, wherein the fan is configured to be locatedon a top portion of the frame. In some embodiments, wherein the filteris configured to remove contaminants from the pressurized air. In someembodiments, wherein the fan comprises an air director, wherein the airdirector is configured to adjust the direction of an airflow of the fan.In some embodiments, wherein the drape further comprises at least oneslit. In some embodiments, wherein the at least one slit provides anoutlet for an airflow generated by the at least one fan to exhaust.

In some embodiments, the device further comprises a surgical tray,wherein the drape is configured to be coupled to the surgical tray,wherein the surgical tray is configured to be releasably attached to thedrape. In some embodiments, wherein the surgical tray further configuredto substantially form a seal between the drape and the surgical trayalong one or more edges of the surgical tray. In some embodiments,wherein the surgical tray comprises a power source for powering the fan.In some embodiments, wherein the surgical tray comprises a controlsystem for controlling the fan. In some embodiments, wherein the fan ispositioned on the surgical tray.

In some embodiments, wherein the drape is configured to be positionedover a surgical patient platform. In some embodiments, wherein thesurgical tray is configured to be coupled to a tray support. In someembodiments, wherein the tray support surrounds a surgical patientplatform. In some embodiments, wherein the tray support is adjacent to asurgical patient platform. In some embodiments, wherein the tray supportcomprises a support bar, wherein the surgical tray is configured to becoupled to the support bar.

For purposes of this summary, certain aspects, advantages, and novelfeatures of the invention are described herein. It is to be understoodthat not necessarily all such advantages may be achieved in accordancewith any particular embodiment of the invention. Thus, for example,those skilled in the art will recognize that the invention may beembodied or carried out in a manner that achieves one advantage or groupof advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features, aspects and advantages of the presentinvention are described in detail below with reference to the drawingsof various embodiments, which are intended to illustrate and not tolimit the invention. The drawings comprise the following figures inwhich:

FIG. 1A. depicts an example of one embodiment of a sterile surgicaldrape system configured to be used in conjunction with a surgical trayfor ophthalmic surgery.

FIG. 1B. depicts an example of one embodiment of a sterile surgicaldrape system.

FIG. 1C. depicts a top view of an example of one embodiment of a sterilesurgical drape system.

FIGS. 1D-1E. depict side views of an example of one embodiment of asterile surgical drape system.

FIG. 1F. depicts an example of one embodiment of a sterile surgicaldrape system with a fan on the surgical tray.

FIG. 1G. depicts an example of one embodiment of an airflow within asterile surgical drape system with a fan.

FIG. 1H. depicts an example of one embodiment of a sterile surgicaldrape system sealed to the surgical tray.

FIG. 2A-C. depicts an example of one embodiment of a frame of a sterilesurgical drape system.

FIG. 2D-E. depicts an example of one embodiment of a frame of a sterilesurgical drape system with legs.

FIG. 2F. depicts an example of one embodiment of a drape and framesystem of a sterile surgical drape system.

FIG. 2G. depicts an example of one embodiment of a leg of a frame of asterile surgical drape system.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Embodiments of the invention will now be described with reference to theaccompanying figures. The terminology used in the description presentedherein is not intended to be interpreted in any limited or restrictivemanner, simply because it is being utilized in conjunction with adetailed description of certain specific embodiments of the invention.Furthermore, embodiments of the invention may comprise several novelfeatures, no single one of which is solely responsible for its desirableattributes or which is essential to practicing the inventions hereindescribed.

As used herein, the term “drape system” is a broad term that can referto a device or apparatus comprising a drape, a frame and/or additionalfeatures.

The disclosure herein provides methods, systems, and devices forperforming ophthalmic surgery in a sterilized field. A sterileophthalmic surgical drape system can beneficially provide a user, suchas a doctor, surgeon, nurse, or assistant with a sterilized environmentin which to perform a medical procedure. The ophthalmic surgical drapesystem can provide the sterile workspace and can be in a configurationthat is ready to use after opening a frame and/or attaching a drape.

Use of a drape system can permit a medical procedure to be performedoutside of an operating room by providing a sterile field. For example,a doctor, surgeon, nurse, assistant and the like can perform a procedurein nontraditional locations such as a doctor's office or a militaryoperating room war setting.

The need for a sterile environment in which to perform surgery reducesthe flexibility of users like doctors, surgeons, and nurses to operatein locations such as their own offices. Also, considerations ofoperating room economics become necessary to optimize operating roomprocedure throughput. As a result, doctors must schedule operation timesin high-cost operating rooms, taking into account not just their ownavailability but those of the entire hospital. A sterile ophthalmicsurgical drape system has the corresponding effects of decreasing theexpensive costs associated with staffing and maintaining a sterilizedoperating room and increasing the number of procedures thatpractitioners can perform and the locations in which they may performthem, which constitute limiting factors in health care efficiency.

Surgical Drape System for Use in Surgical Procedures

In some embodiments, an ophthalmic surgical drape system is configuredto be placed substantially over a patient's eye(s) and provide a sterilefield underneath a drape. The ophthalmic surgical drape system cancomprise a fan configured to generate a controlled airflow through thearea underneath the drape to substantially prevent contaminants fromentering the area underneath the drape.

In some embodiments, a drape system can be used alone and/or inconjunction with a sterile surgical tray and system. FIG. 1A illustratesone embodiment of a sterile ophthalmic surgical drape system 100configured to be used in conjunction with a surgical tray 106 forophthalmic surgery. In the depicted embodiment, a surgical drape system100 is configured to be attached substantially above a surgical tray 106to provide a sterile field underneath the surgical drape system 100. Insome embodiments, the surgical drape system 100 drapes over the surgicaltray 106 and substantially forms a seal along one or more edges of thesurgical tray 106.

The combination of a drape system 100 and a surgical tray 106 can allowa doctor, surgeon, nurse, assistant and the like to perform anophthalmic medical procedure in a sterile field outside of an operatingroom without having to acquire additional materials or assistance.Alternatively, a doctor, surgeon, nurse, assistant and the like may needa minimal amount of additional materials or assistance. In someembodiments, in addition to providing one or more surgical toolsrequired for a medical procedure, the tray 106 can provide a powersource and control systems for those tools, which are housed within thesterile surgical field created by the drape system 100.

In a medical procedure, such as ophthalmic surgery, a surgical tray 106or at least one or more surfaces thereof can be part of the sterilefield created by a sterile ophthalmic surgical drape system 100. In sucha configuration, the surgical tray 106 can serve as a location on whichto place or hold previously sterilized medical tools, instruments ormedications. In some embodiments, by fitting an ophthalmic surgicaldrape system 100 on the circumference of a surgical tray and system 106,a user such as a doctor, surgeon, nurse, assistant, or the like canaccess all necessary surgical tools, instruments, or medications in asterilized field in a fashion that has been tailored to be the mostefficient organization for a medical procedure.

The surgical tray 106 can be of any type, currently known or to bedeveloped in the future. For example, the surgical tray 106 can comprisesterile instruments and materials necessary for surgery to make themreadily available to a nurse or surgeon. In certain embodiments, thesurgical tray 106 can also comprise an electrical connector, a fluidconnector, a pump, and/or control unit.

In some embodiments, the drape system 100 can attach to the surgicaltray 106 via an attachment mechanism. For example, the attachmentmechanism can comprise a screw, Velcro, mechanical interlocking, or thelike. In certain embodiments, the attachment mechanism is permanent,semi-permanent, and/or temporary for easy assembly and/or disassembly.In some embodiments, the attachment mechanism is configured tosufficiently secure the drape system 100 such that it could not belifted off the top of the patient inadvertently.

In some embodiments, the drape system 100 can be detached and liftedfrom the surgical tray 106 to allow a patient to be removed. In certainembodiments, the patient can be pulled out laterally through thesidewall of the drape system 100 without having to detach the drapesystem 100 from the surgical tray 106.

In some embodiments, a sterile ophthalmic surgical drape system 100 doesnot contact the patient in order to provide a user, for example, adoctor, surgeon, nurse, or assistant with maximum access to a patient'shead. For example, in certain embodiments, the drape system 100 fits onthe circumference of the tray and extends generally upward.

In some embodiments, a drape system 100 alone and/or in conjunction witha surgical tray 106 can be placed on top of or connected to a surgicalchair 102, table, or the like. In other embodiments, the drape system100 alone and/or in conjunction with a surgical tray 106 can be placedon top of or connected to an apparatus, such as a tray support 104, thatsurrounds or is adjacent to a surgical chair 102, table, or the like. Incertain embodiments, the drape system 100 and tray 106 can be placed onor connected to a support bar of a tray support 104. The drape system100 and surgical tray 106 can be placed on or connected to theapparatus, such as the tray support 104 or support bar of a tray support104, in one of many different ways.

A tray support 104 or a support bar of the tray support can have a fixedor adjustable position relative to the surgical chair 102, table, or thelike to which it is connected. A tray support 104 can be used forpositioning the drape system 100 and tray 106 above a patient's headwhen the patient is lying on a surgical chair 102 or the like with hisor her head positioned on a headrest. The tray support 104 can securethe sterile field of the drape system 100 in which a user, such as adoctor, surgeon, nurse, assistant or the like will be performing amedical procedure, such as an ophthalmic surgery.

A tray support 104 can surround a patient's head. This can act as aresting structure in the sterile field created by the drape system 100on which a doctor, surgeon, nurse, assistant or the like may place hisor her hands or arms during a medical procedure.

A support bar of a tray support 104 may have one of many differentshapes. As depicted in one example of an embodiment in FIG. 1A, a traysupport 104 may have a support bar with a U-shaped ring. In otherembodiments, the support bar can be substantially circular,semi-circular, V-, or L-shaped, or a box with three sides.

A support bar of a tray support 104 may be manufactured from asubstantially round or square bar, tube, or pipe. For example, asillustrated in FIG. 1A, a support bar with a U-shaped ring can bemanufactured from a substantially square tube.

In some embodiments, a drape system 100, alone or in combination with asurgical tray 106, may be manufactured and shipped in a pre-sterilizedpackage, for example through an ethylene oxide sterilization process,from a manufacturer to a customer, such as a hospital, doctor's office,military location, or the like. The drape system 100 can be used by asurgeon, doctor, nurse, assistant or the like to perform any medicalprocedure, including but not limited to ophthalmic surgery.

In certain embodiments, the entire drape system 100 is disposable afteruse, while in other embodiments, one or more individual components ofthe drape system 100 are disposable after use and one or more individualcomponents are reusable. For example, the one or more individualcomponents can include a pressurizing fan, frame leg(s), and drape,among others.

In some embodiments, a sterile surgical drape system 100 can compriseone or more features to provide a sterile environment and/or assist amedical procedure, such as ophthalmic surgery. For example, in someembodiments, a sterile surgical drape system 100 can comprise a hole inthe drape for a microscope, a pressurizing fan, air directors, and/orslits in the drape among others. FIGS. 1B-1E illustrate different viewsof one embodiment of a sterile surgical drape system 100. In particular,FIG. 1B depicts a three-dimensional view of an example of one embodimentof a sterile surgical drape system 100.

In an embodiment, a sterile surgical drape system 100 comprises a frame118 and a drape 120 placed over the frame. In some embodiments, thedrape 120 is permanently, semi-permanently and/or temporarily attachedto the frame 118 for easy assembly and/or disassembly. For example, thedrape 120 can be glued to the frame 118. In other embodiments, the drape120 is not glued but simply sits on top of the frame 118. The drape 120is stabilized above the frame 118 as a result of friction between thedrape 120 and the frame 118. In certain embodiments, the drape 120 isattached to the frame 118 via one or more mechanical features, includingbut not limited to a clip, hinge, perforation, or the like.

Drape

A surgical drape 120 may be provided over the patient during surgery tomaintain a sterile surgical field. FIG. 1B illustrates an example of oneembodiment of a sterile surgical drape system. The drape 120 may have aproximal side which faces the patient or patient support apparatus suchas a chair or surgical table. The distal side of the drape faces upwardtoward the surgeons or medical professional. The drape 120 can beprovided over a supporting structure or frame 118. The drape 120 can bea flexible or elastic material that conforms in shape to any shape ofthe frame 118. The frame 118 can have legs 114 as illustrated in FIG.1B. The frame 118 and legs 114 can contact the proximal side of thedrape and provide structure or support for the drape creating aninterior chamber within the drape. For example, the drape can beprovided over a rectangular frame and create a rectangular chamber wherethe walls and the top of the chamber are formed by the drape. Further,in some embodiments, the top surface of the drape and frame system canbe formed of a Plexiglas or other rigid material. The bottom of thechamber can be open to the atmosphere and not covered by the drape. Insome embodiments, the drape and frame can be provided over a surgicaltray and thereby the bottom of the chamber can be enclosed or partiallyenclosed by the surgical tray as described in detail herein. The drapeand frame system can be sealed entirely around the periphery to thetray. In some embodiments, the drape 120 and/or the frame 118 system canbe sealed or substantially sealed to the surgical tray 106 asillustrated in FIG. 1H. In order to ensure that airflow out of thesurgical chamber is through the hole 108, the area surrounding thepatient's head 140, and the slits 110 and/or the openings for the handsof the surgeon and not through the drape-tray interface.

An ophthalmic surgical drape 120 may be manufactured from a variety ofmaterials. For example, in some embodiments, a drape 120 may bemanufactured from a transparent material, including but not limited toany transparent polymer. This can permit a user, such as a doctor,surgeon, nurse, assistant, or the like, to have optimum visibilityduring a medical procedure. In other embodiments, the drape 120 may bemanufactured from an opaque material, such as cloth or opaque polymer.If an opaque drape 120 were used on the panels instead of a transparentdrape, then the user's visibility may be limited. In some embodiments,the drape 120 may have one or more panels in the drape 120 manufacturedfrom an opaque material and one or more panels in the drape 120manufactured from a transparent material.

In some embodiments, the drape 120 may be disposable. In someembodiments the drape 120 may be a pre-sterilized drape 120 manufacturedand shipped in a pre-sterilized package to a customer, such as ahospital, doctor's office, military location, or the like. For example,the drape 120 may be sterilized through an ethylene oxide sterilizationprocess.

In some embodiments, the thickness of the drape 120 can be about 0.001inches, about 0.002 inches, about 0.003 inches, about 0.004 inches,about 0.005 inches, about 0.006 inches, about 0.007 inches, about 0.008inches, about 0.009 inches, about 0.010 inches, about 0.020 inches,about 0.030, about 0.040 inches, about 0.050 inches, about 0.060 inches,about 0.070 inches, about 0.080 inches, about 0.090 inches, about 0.100inches, or any other thickness.

In certain embodiments, the drape 120 can further comprise one or moreholes 118 for one or more microscopes, fans, filters, air directors,and/or slits, among others. The walls or sides of the drape can haveslits 110 as illustrated in FIG. 1B. The slits 110 can be positionedvertically on the side of the drape. The slits 110 can allow a user toaccess the interior of the chamber formed by the drape. In someembodiments, the drape 120 can have a hole 108 provided through thedrape 120. The hole 108 can also allow access to the interior of thedrape chamber. The drape can be on the top and/or a side of the drapechamber. FIG. 1B illustrates a hole 108 positioned on the top of thedrape 120. The hole 108 can be in the center of the drape or offset fromthe center depending on the intended use of the hole 108. In someembodiments, a hole 108 can be positioned on a side panel of the drape120. The hole 108 can allow an accessory device to access the interiorof the drape chamber. The accessory device can be a microscope, a fan, asurgical tool, an air director, a filter, or any accessory device asdescribed herein. For example, as illustrated in FIG. 1B, a fan 112 canbe positioned within a hole 108 in the dressing. The fan 112 can haveair directors 116 operating in conjunction with the fan to provide apressurized and directed airflow beneath the surgical drape and withinthe chamber as described in more detail herein.

Opening in Drape for Microscope

Regardless of whether a drape 120 is composed of a transparent and/oropaque material, it can be advantageous for a surgeon, nurse, or thelike to visualize a surgical area underneath the drape via a microscope.The drape material even though translucent, can still create a viewthrough the microscope that is unclear or obscured because of thematerial. Accordingly, in some embodiments, the drape 120 comprises oneor more holes to allow a microscope(s) 130 to enter into the drapeand/or view the surgical area without the obscuring effect of the drapeas illustrated in FIG. 1B.

FIG. 1C shows a top view of a patient lying down on his or her back withan embodiment of the drape system 100 surrounding the head of thepatient during a medical procedure. Such a patient can be prepared forany medical procedure, including for example an ophthalmic surgicalprocedure on one or both eyes of the patient.

In some embodiments, the drape 120 comprises one or more openings orholes 108 positioned over one or both eyes of the patient. The size ofthe hole 108 can be substantially the same size or larger than surgicalmicroscopes that are generally used in ophthalmic surgery. A hole in thedrape for the microscope 108 can permit visibility into the sterilizedfield by reducing a risk of reflections between, for example, a fiberoptic in the eye and a drape material. In other embodiments, one or moreopenings for a microscope 108 can be positioned on any of the sidesurfaces or corners of the drape. In certain embodiments, the one ormore openings are further configured to be used for insertion of othersurgical tools.

In some embodiments, the hole 108 can have a recess that extends in tothe interior of the drape chamber, as shown in FIG. 2F. In someembodiments, the drape hole 108 can be perforated or have perforatedcutouts in the drape material at the bottom of the recess. Theseperforations can allow for easy removal of the drape material that isover the operating area, allowing direct access and viewing of thesurgical area with the microscope. For example, the microscope 130 canbe placed over the hole 108 directly over the patient's surgical area,such as the eye. The recess in the hole 108 can have two sets ofperforated cutouts at the bottom, one for the right eye and one for theleft eye. The cutouts can be removed depending on which eye is beingoperated on. With the removal of this cutout, the microscope can have anunobstructed view of the eye during the surgical procedure.

Fan

In order to provide a sterile field underneath the drape 120, it can beadvantageous to provide a steady pressurized air underneath the drape120. The fan can operate in coordination with a filter which sterilizesor cleans the air entering the drape as described in detail herein. Insome embodiments, the fan can be motorized. Accordingly, in someembodiments, an ophthalmic surgical drape system 100 comprises one ormore pressurizing fans that draw air into the drape. In someembodiments, as shown in FIG. 1B-1D, the hole 108 can allow for a fan112 to be positioned within the hole 108. The fan 112 can be sealedaround it periphery in the hole 108 to prevent air from entering thesurgical field.

In some embodiments, the fan 112 can be permanently attached to thedrape system 100. The drape and frame system and the attached fan can bepackaged and used as a single integrated unit. For example, the singleintegrated unit allows for the user to take the drape system out of thebox, expand it, and place it over the surgical area, thereby simplifyingthe preparation and additional equipment traditionally necessary for thesurgical procedure. Further, this integrated fan can eliminate the useof tubing or lines running from the drape system to a remote pressuresource which can interfere with the surgeon during the surgicalprocedure. Additionally, the integrated fan allows for easy assembly anduse of the system in the field or in a physician's office by reducingthe amount of space occupied and the assembly required for an externalfan or pressure source. For example, the user can simply attach thedrape and frame system with the integrated fan to the tray with noadditional assembly or attachment required. Also, the incorporated fanmitigates the need for the surgeon to have an expensive pressurizationsystem in the physician's office. This system is also advantageousbecause it allows the surgeon to avoid using an expensive operating roombecause it is easily deployable in the field or in a physician's officewhile creating the necessary sterilized environment.

The fan 112 can be provided on a side or on the top of the drape 120.FIG. 1D illustrates side views of an example of one embodiment of asterile surgical drape system 100. In the depicted embodiment, a fan 112is located on the left side panel of an ophthalmic surgical drape system100. In other embodiments, the fan 112 can be located on the right sidepanel of an ophthalmic surgical drape system 100 and/or any other panel.The location may depend on the inclination of the doctor or surgeon, whomay, for example, want his or her assistant on the right or left side ofthe surgical drape. The left or right side panel of the surgical drapesystem 100 is defined as being the panels immediately adjacent to thepanel in which a doctor or surgeon inserts his or her hands to perform amedical procedure while looking substantially down at a patient. Inanother embodiment, the fan can be located on the tray as illustrated inFIG. 1F. The fan can be integrated into the tray and provide thepressurized air to the chamber of the drape without additional holes inthe drape. The fan can be configured to draw power from the tray.Additionally, an embodiment where the fan is integrated into the traycan simplify the design of the drape and the frame system. The fan canbe positioned on the top and/or side surfaces of the tray. In someembodiments, the fan can also be positioned within the tray. In anembodiment, the sterilized air generated by the fan in the tray can bedirected through channels in and/or on the tray to a plurality of portspositioned in various positions on the tray. The ports can be positionedon the side, outer parameter, and/or the top surface of the tray. Theplurality of ports can allow for the sterilized air to be evenlydistributed throughout the interior surgical chamber. In an embodiment,the plurality of ports can be configured to allow for the sterilized airto be directed in various directions within the interior surgicalchamber. In an embodiment, the plurality of ports can be configured tomore evenly distribute the delivery of sterilized air to the interiorsurgical chamber to mitigate possible harmful air current drafts duringsurgery.

In some embodiments, the fan 112 can be mounted to parts of the frame118 as illustrated in FIG. 2A. The frame can have a lower rim 206 and anupper rim 204. In some embodiments, the lower rim 2006 can extend thefull circumference of the drape system except the section in which thepatient's head is to be provided. In some embodiments, the upper rim 204can extend the full circumference of the drape system including thesection that extends over the patient's body or head. In someembodiments, the fan 112 can be mounted to the lower rim of the frame206 of the sterile ophthalmic surgical drape system and part of one ormore legs 114 of the frame 118 of the sterile ophthalmic surgical drapesystem 100. The advantage of mounting the fan 112 in this position isthat it does not result in weight being added to the upper rim of theframe 204 of the sterile ophthalmic surgical drape system 100. In otherembodiments, the fan 112 can be mounted to the lower rim of the frame206 of the sterile ophthalmic surgical drape system 100. In otherembodiments, the fan 112 can be mounted to part of one or more legs 114of the frame 118. In some embodiments, the fan can be mounted to theupper rim of the frame 204. In some embodiments, the fan 112 can bemounted to the upper rim 204 of the frame and part of one or more legs114 of the frame 118.

In some embodiments, a fan 112 can be in electrical communication withthe surgical tray 106 through a plug and access its power from the tray106. In other embodiments, a sterile drape system 100 can have one ormore battery sources from which the fan 112 may draw power. For example,one or more battery sources can be located inside one of the legs 114 ofthe frame 118 in the sterile drape system 100. In another example, oneor more battery sources could be located on the upper rim 204 or lowerrim 206 of the frame. In certain embodiments, a fan 112 may have one ormore battery sources within the fan 112 from which it may draw power.

Additionally, in some embodiments, the air from the fan can bepositioned or directed in a particular direction within the chamber byutilizing air directors 116. As illustrated in FIG. 1C, in someembodiments, the fan 112 can have one or more air directors 116positioned adjacent to the fan 112. The air directors 116 can bepositioned on either side, on the top, and/or on the bottom of the fan112. The fan 112 may be positioned in one of many directions. In someembodiments, the fan 112 can be positioned in such a way as to provideairflow across a patient's eyes as described in detail herein. Forexample, FIGS. 1B-1D depict an example of one embodiment of positioningthe fan 112 towards the edge of a leg 114 of the drape system 100. Inother embodiments, the fan 112 may be positioned substantially in thecenter of the left or right panel of an ophthalmic surgical drape system100. In some embodiments, the fan 112 may be positioned in between theedges of a leg 114 of the drape system 100.

In some embodiments, slits 110 can be provided on the drape 120 to allowfor air within the chamber to be exhausted through the slits. In someembodiments, the slits can also be used by the surgeon or other user toinsert their hands or tools into the drape chamber. Further, in someembodiments, the pressurized airflow provided by the fan 112 and airdirectors 116 can create a sterile surgical field within the chamber.

In some embodiments, even though the interior surgical chamber createdby the drape 120 and frame 206 connected to the tray 106 is not fullysealed or closed off to the surrounding environment, a sterile field canbe created in the interior surgical chamber by providing a steady andcontinuous pressurized airflow and environment within the interiorchamber of the drape 120. The American Hospital Association (AHA)recommends that operating rooms keep air circulating at all times. Theair within the operating room should not become stagnant because thelack of circulating air increases the risk of infection or contaminationof the surgical site and/or surgical materials, especially in thecontext of ophthalmic surgery. The AHA has requirements for operatingroom ventilation and, according to the AHA, the rate at which the airmust change in the room is approximately between 20 to 300 times perhour. In an embodiment, the airflow can be directed over the patient'sface or across the patient's face and thereby meet the requirements forsurgical procedures. The surgical drape system as described hereinallows for airflow and a rate of exchange of air within the interiorsurgical chamber that can meet the forgoing air circulation requirementswithin the interior surgical chamber. The circulating air within thechamber as described herein can create a regulation compliant surgicalarea that can be used in a physician's office or in the field withoutthe need for additional and expensive equipment or operating roomsequipped with the ventilation systems. The surgical drape system cancreate airflow generated by motorized fan, wherein the airflow isapproximately 22 m² per hour, 24 m² per hour, 26 m² per hour, 28 m² perhour, 30 m² per hour, or 32 m² per hour.

FIG. 1G illustrates an example of one embodiment of airflow within asterile surgical drape system as generated by a motorized fan. In someembodiments, pressurized air 151 can be released into the chamber by thefan 112. The air 151 entering the chamber through the fan 112 can befiltered and the fan 112 can produce contaminant free and/ordecontaminated air 151. During the surgical procedure, a patient 141 canrelease or exhale contaminated air from the nose and/or mouth 152 of thepatient 141. The contaminated air can increase the risk of infection orcontamination of the surgical site. The contaminated exhaled air 152 canbe directed away from the surgical site of the interior chamber byallowing the exhaled air to flow out of the interior chamber throughopenings in the surgical drape system, as illustrated in FIG. 1G. Thepressurized contaminant free airflow released by the fan 112 into theinterior chamber can create a sufficiently high flow rate to force airwithin the drape 120 outward leaving the contaminant free filtered airwithin the drape 120. As shown in FIG. 1G, the air can flow out of thedrape chamber through the hole 108, the area surrounding the patient'shead 140, and the slits 110 and/or the openings for the hands of thesurgeon, as depicted with airflow arrows 150 in FIG. 1G. The airmovement and airflow can create a rate of air exchange within the drapethat can meet operating room requirement.

Additionally, the creation of the pressurized environment creates an airpressure differential between the interior chamber of the drape and theambient environment of the surgical room. This pressure differential isadvantageous for a surgical procedure, in particular ophthalmic surgery,because it prevents ambient air from entering the interior chamber ofthe drape. In certain instance, the ambient air can comprisecontaminants or other materials that can cause infection at the surgicalsite. The creation of the pressure differential prevents suchcontaminated air from entering the sterile surgical area of the drape.The pressure range for the pressurized airflow supplied from the fan canbe about 0.5 psi, about 1 psi, about 2 psi, about 3 psi, about 4 psi,about 5 psi, about 6 psi, about 7 psi, about 8 psi, about 9 psi, andabout 10 psi. In some embodiments, the pressure can be about 1 psi toabout 2 psi.

The fan 112 can keep the drape pressurized so that there is an outgoingairflow from the interior of the drape system 100 to the surroundingarea, with substantially no air flowing into the sterilized chamberexcept through the fan 112. By limiting the air entering the sterilechamber substantially to the fan 112, the fan 112 may preventcontaminants from entering the surgical site, for example a patient'seye(s), when the patient is in the sterile surgical field. In someembodiments, the fan 112 comprises one or more selectable velocities toprovide a selectable amount of airflow in the closed chamber. The one ormore selectable velocities of the fan 112 can be any value between 20-45cubic feet per minute. In some embodiments, the fan 112 may keep enoughair pressure in the chamber so that there is a substantially positiveflow of air out of the drape system 100. In some embodiments, the fan112 can be configured to generate laminar airflow.

In some embodiments, a drape system comprises more than one fan 112. Incertain embodiments, the more than one fan 112 is positioned such thatair flows in the same direction.

In certain embodiments, the drape system 100 comprises a vibration-freefan 112 to minimize vibration of the drape system 100. In someembodiments, the drape system 100 comprises a vibrating fan 112 coupledto vibration-absorbing material that is configured to minimize vibrationof the drape system 100.

In some embodiments, the drape system comprises tubing instead of a fan.A tube, connected to an air source located outside of the sterilizedchamber of a sterile ophthalmic surgical drape, can be inserted into anopening on the side panel of the ophthalmic surgical drape. An airsource, for example sterilized air or oxygen, may be activated throughthe tubing. The air source may provide positive air pressure into thesterilized chamber and provide a substantially outward flow of air fromthe sterilized chamber to the external environment. Although both oxygenand sterilized air could be used, sterile air may be preferable tooxygen because oxygen may, in some instances, present a flammabilityrisk.

Filter

In order to further provide and maintain a sterile field, it can beadvantageous to install one or more air filters to the drape system tosubstantially prevent contaminants from entering the chamber in whichthe procedure is being performed. Accordingly, in some embodiments, thedrape system comprises one or more air-cleaning filters attached and/orcoupled to the various embodiments of the fan as disclosed herein. Forexample, the filter can be a High-Efficiency Particulate Air (“HEPA”)filter or the like. In certain embodiments, the one or more filters thatcan be installed can be HEPA filters with efficiencies of at leastapproximately 99.97 percent on all airborne particulate matter 0.3micron in diameter and larger.

In some embodiments, a cross-sectional area of the one or more filtersis substantially equal to a cross-sectional area of the fan. In certainembodiments, a cross-sectional area of the one or more filters is largerthan a cross-sectional area of the fan.

In some embodiments, one or more filters may be located on the exteriorside of the fan. In certain embodiments, one or more filters may belocated on the interior side of the fan. In other embodiments, one ormore filters may be located in between the exterior and interior sidesof the fan.

Air Director

In embodiments where the drape system 100 comprises one or more fans112, it can be envisioned that airflows with different paths may bepreferred for different patients and/or situations. Accordingly, in someembodiments, the airflow of one or more fans 112 of a sterile ophthalmicsurgical drape system 100 is adjustable. FIGS. 1B-1D illustrateembodiments of a fan 112 with one or more air directors 116.

In certain embodiments, a drape system 100 comprises one or more airdirectors 116 coupled to one or more fans 112. For example, the one ormore air directors 116 can be attached to the one or more fans 112 inthe interior and/or exterior of the drape system 100. In someembodiments, the one or more air directors 116 can allow a user, forexample a doctor, surgeon, nurse, or assistant, to control the airdirectors 116 from inside the drape system 100. In other embodiments,the fan 112 is controllable on the outside by, for example, the doctoror surgeon's assistant. The control of the airflow direction can allowthe surgical drape system to provide an airflow or pressurized airflowacross the surgical field, for example the patient's face that satisfiesthe operating room requirements discussed herein.

Slits

FIGS. 1B-1E depict an example of one embodiment of a sterile ophthalmicsurgical drape system 100 with substantially vertical slits 110 in thepanels of the drape 120. In other embodiments, the slits 110 in thepanels of the drape 120 may be oriented in one of many positions such assubstantially horizontal or diagonal. The slits 110 can be configured toallow the airflow within the drape to exit. In some embodiments, thedrape 120 comprises one or more outlets to allow the airflow generatedby a fan(s) to exhaust.

In some embodiments, the one or more slits 110 are further configured toallow a user to insert his or her hands into the sterile field. In someembodiments, as depicted in an example in FIGS. 1B, 1C, and 1E, theremay be one or more slits 110 in the panel of the drape 120 that face thesurgeon. For example, the panel of the drape 120 that faces the surgeoncan comprise two slits so the surgeon can insert both hands into thedrape.

FIG. 1C depicts an example of an embodiment in which there are no slitson a top panel with a hole of sufficient size for a microscope 108.However, in other embodiments, there may be one or more slits 110 in thetop panel.

FIG. 1D depicts an embodiment in which there are no slits down the sidepanel of the drape system 100 that contains the fan 112. In otherembodiment, there can be one or more slits 110 in the side panel of thedrape system 100 that contains the fan 112. In some embodiments, theside panel of the drape system 100 where the fan 112 is locatedcomprises one or more holes to allow air to flow into the fan.

On the side opposite of the panel with the fan 112, there can be one ormore slits 110. The slits can allow a user, such as an assistant ornurse, to reach his or her hands into a sterile chamber to assist, forexample, a doctor or surgeon.

Looking to FIG. 1E, the panel opposite to the panel facing a doctor mayprovide no slits where the patient's head rests beneath the drape system100 and surgical tray 106. In other embodiments, the panel opposite tothe panel facing a doctor may have one or more slits 110.

In some embodiments, the one or more slits 110 in one or more panels ofa sterile ophthalmic surgical drape 120 extend substantially to thebottom of the surgical drape 120. In other embodiments, the slits do notextend substantially to the bottom of the surgical drape 120.

Frame

It can be advantageous for a drape system to comprise a frame or otherrigid structure to maintain the drape's position over a patient and toprovide sufficient space for a surgeon or other medical professional towork. Accordingly, in some embodiments, a drape system comprises a framewith the drape located over the frame.

A frame apparatus 118 of an ophthalmic surgical drape system 100 can bea sterile frame that has been manufactured and assembled as aprepackaged sterile frame comprising, among other materials,injection-molded, acrylonitrile butadiene (“ABS”) plastic. In certainembodiments, the frame 118 can be substantially transparent to allow forbetter visualization of the surgical area.

The frame 118 can have one of many different shapes. For example, theframe 118 can be substantially spherical, pyramidal, conical, orrectangular. FIG. 2A-2F depict an embodiment in which the frame 118 issubstantially rectangular. In another embodiment, the upper rim of theframe 204 may have increased curvature to provide a user with additionalvantage points so the user may view a patient from a position other thandirectly below the user.

FIGS. 2A-2F illustrate an example of one embodiment of a frame apparatus118 of an ophthalmic surgical drape system 100. The frame 118 can beconfigured to allow the frame and drape to be attached to a surgicaltray. The frame can have an upper rim 204, a lower rim 206, and legs114. The drape can be provided over the upper rim 204 of the frame 118.In some embodiments, when the frame is in the expanded configuration,the legs 114 have a distal end located farthest from the patient and aproximal end located closest to the patient as illustrated in FIG. 2A.The distal end of the legs 114 are configured to contact the upper rim204 of the frame when in the expanded configuration. The upper rim 204and the legs 114 provide the support for the surgical drape. Theproximal end of the legs 114 are configured to connect to the lower rim206 of the frame when in the expanded configuration. The lower rim 206can attached to a surgical tray as described herein.

In some embodiments, the upper rim 204 and the lower rim 206 can havethe same or substantially the same circumference as the surgical tray.In some embodiments, the upper rim 204 and the lower rim 206 can have asmaller or larger circumference than the surgical tray. In someembodiments, the upper rim 204 and the lower rim 206 can havesubstantially the same circumference. In other embodiments, the upperrim 204 and the lower rim 206 can have a substantially differentcircumference. FIG. 2A depicts an embodiment in which the lower rim ofthe frame 206 may extend all around the circumference of a surgical tray106 to which it may be connected, except where a patient positions hisor her head. The upper rim of the frame 204 may extend all around thecircumference of the tray 118, including where the patient positions hisor her head.

The frame 118 can comprise one or more substantially vertical legs 114.In certain embodiments, one or more legs 114 can connect a lower rim ofthe frame 206 to an upper rim of the frame 204. For example, in FIG. 2A,four legs 114 connect the lower rim of the frame 206 to the upper rim ofthe frame 204.

In some embodiments, the frame 118 may be collapsible. The frame 118 maybe manufactured and shipped in a collapsed configuration in a packagefrom a manufacturer to a customer, such as a hospital, doctor's office,military location, or the like. The package may be a pre-sterilizedpackage. For example, the package may be sterilized through an ethyleneoxide sterilization process. FIG. 2C depicts an example of oneembodiment of a frame apparatus 118 in its collapsed form. When a frame118 is collapsed, the upper rim of the frame 204 and the lower rim ofthe frame 206 can be substantially in contact with each other.

In some embodiments, to apply the frame 118, a party may connect theframe apparatus 118 to a surgical tray 106 and raise the upper rim ofthe frame 204. As shown in FIGS. 2A and 2B, the one or more legs 114rise and lock in a substantially upright, vertical position to securethe frame apparatus 118. The one or more legs 114 connect the lower rimof the frame 206 to the upper rim of the frame 204 at hinges 202 locatedon the lower rim of the frame 206.

In some embodiments, to disassemble the frame apparatus 118, the frameapparatus may be disconnected from the surgical tray 106 or tray support104 or the like. A party may apply a force to the frame apparatus tounlock the one or more legs 114 at the hinges 202 connecting the lowerrim of the frame 206 to the upper rim of the frame 204. The one or morelegs 114 of the frame apparatus 118 may fold in one of many differentdirections. For example, as illustrated in FIG. 2C, the one or more legsmay fold in a substantially inward direction relative to the frameapparatus 118. Alternatively, the one or more legs may fold in asubstantially outward direction relative to the frame apparatus 118.

In other embodiments, the hinges 202 may be located in between the twoends of the one or more legs 114. For example, FIGS. 2D-2F depict anexample of one embodiment of a frame apparatus 118 in which the hinges202 may be located substantially at the center of one or more legs 114.The hinge 202 can operate as described herein with reference to FIG. 2G.

FIG. 2F illustrates an example of an embodiment of a frame 118 with adrape 120 disposed over the frame in an expanded configuration. Theframe can have an upper rim 204, a lower rim 206, and legs 114 therebetween as described in detail herein. Further, in some embodiments, thelegs 114 can connect to the upper rim 204 and the lower rim 206 withattachment mechanisms such as hinges 202 or other attachment mechanismsas described herein. In some embodiments, the hole 108 can be positionedin the center of the drape to allow for access of surgical tools oraccessory devices, such as a microscope, a fan, or other surgical toolsas described herein. Additionally, in some embodiments, the drape andframe system can have a fan 112 that can allow for controlled access ofairflow into the chamber.

FIG. 2G illustrates an example of an embodiment in which the one or morelegs may be deformable. The legs 114 may bend or fold to allow the frameto collapse or fold. This deformable leg allows the frame to be easilymoved and/or stored. In some embodiments, the legs 114 may fold at thehinges 202, which may be located substantially at the center of the oneor more legs 114. The legs 114 may fold in a substantially inwarddirection relative to the frame apparatus 118. In other embodiments, theone or more legs 114 may fold at the hinges 202 that may be locatedsubstantially at the center of the one or more legs 114, in asubstantially outward direction relative to the collapsed frameapparatus 118. The hinge 202 in the center of the legs 114 allows theframe to be fully collapsible and expandable with the legs foldedbetween the lower rim and the upper rim of the frame. The hinge 202 inthe leg can allow for the frame to collapse into a flat configurationwithout the need for detaching a portion of the leg 114 from either theupper or lower rim. The legs 114 can therefore remain permanentlysecured to the frame. This provides the surgeon with an easilyexpandable and collapsible sterile surgical field that can be expandedin an office or in the field without the need for additional tools tosecure the legs 114 to the frame.

In some embodiments, a frame 118 may be manufactured and shipped in aconfiguration in which a lower rim of the frame 206 and one or more legs114 that can connect the lower rim 206 to an upper rim 204 are attachedto a surgical tray 106. The frame may be pre-sterilized. To apply theframe, in some embodiments, the upper rim of the frame 204 may beseparately attachable to the lower rim of the frame 206 and the one ormore legs 114 that can connect the lower rim 206 to the upper rim 204.

Conditional language, such as, among others, “can,” “could,” “might,” or“may,” unless specifically stated otherwise, or otherwise understoodwithin the context as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements and/or steps areincluded or are to be performed in any particular embodiment. Theheadings used herein are for the convenience of the reader only and arenot meant to limit the scope of the inventions or claims.

Although the embodiments of the inventions have been disclosed in thecontext of a certain preferred embodiments and examples, it will beunderstood by those skilled in the art that the present inventionsextend beyond the specifically disclosed embodiments to otheralternative embodiments and/or uses of the inventions and obviousmodifications and equivalents thereof. In addition, while a number ofvariations of the inventions have been shown and described in detail,other modifications, which are within the scope of the inventions, willbe readily apparent to those of skill in the art based upon thisdisclosure. It is also contemplated that various combinations orsubcombinations of the specific features and aspects of the embodimentsmay be made and still fall within one or more of the inventions.Accordingly, it should be understood that various features and aspectsof the disclosed embodiments can be combine with or substituted for oneanother in order to form varying modes of the disclosed inventions.Thus, it is intended that the scope of the present inventions hereindisclosed should not be limited by the particular disclosed embodimentsdescribed above.

What is claimed is:
 1. A device for performing surgery comprising: adrape, the drape comprising a hole configured to allow at least oneaccessory device to be placed in the hole and to access a surgical sitecovered by the drape; a frame, the frame comprising an upper rim, alower rim, and one or more legs, wherein the one or more legs canconnect the lower rim to the upper rim of the frame, wherein the drapeis configured to be coupled to the frame to define an interior surgicalchamber; and a motorized fan, the motorized fan configured to generatepressurized airflow within the interior surgical chamber, the motorizedfan comprising a filter, the filter configured to filter outcontaminants from the pressurized air.
 2. The device of claim 1, whereinthe motorized fan is coupled to the frame.
 3. The device of claim 1,wherein the drape is releasably coupled to the frame.
 4. The device ofclaim 1, wherein the frame is collapsible.
 5. The device of claim 1,wherein the one or more legs are configured to be deformable.
 6. Thedevice of claim 1, wherein the at least one accessory device comprises amicroscope.
 7. The device of claim 1, wherein the motorized fan isconfigured to generate a pressurized air of about 0.5 psi.
 8. The deviceof claim 1, wherein the motorized fan is configured to generate apressurized air of about 1 psi.
 9. The device of claim 1, wherein themotorized fan is configured to generate a pressurized air of about 2psi.
 10. The device of claim 1, wherein the motorized fan is configuredto draw air into the interior surgical chamber.
 11. The device of claim1, wherein the motorized fan is configured to be located on a sideportion of the frame.
 12. The device of claim 1, wherein the motorizedfan is configured to be located on a top portion of the frame.
 13. Thedevice of claim 1, wherein the filter is configured to removecontaminants from the pressurized air.
 14. The device of claim 1,wherein the motorized fan comprises an air director, wherein the airdirector is configured to adjust the direction of an airflow of themotorized fan.
 15. The device of claim 1, wherein the drape furthercomprises at least one slit.
 16. The device of claim 15, wherein the atleast one slit provides an outlet for an airflow generated by the atleast one motorized fan to exhaust.
 17. The device of claim 1, furthercomprising a surgical tray, wherein the drape is configured to becoupled to the surgical tray, wherein the surgical tray is configured tobe releasably attached to the drape.
 18. The device of claim 17, whereinthe surgical tray further configured to substantially form a sealbetween the drape and the surgical tray along one or more edges of thesurgical tray.
 19. The device of claim 17, wherein the surgical traycomprises a power source for powering the motorized fan.
 20. The deviceof claim 17, wherein the surgical tray comprises a control system forcontrolling the motorized fan.